Coupling device for coupling a rod to a bone anchoring element and bone anchoring device with such a coupling device

ABSTRACT

A coupling device is provided for coupling a rod to a bone anchoring element. The coupling device includes a receiving part having a first end, a second end, a central axis extending through the first end and the second end, and a channel for receiving a rod. The receiving part defines an accommodation space for accommodating a head of a bone anchoring element, the accommodation space having an opening for inserting the head. The coupling device further includes a pressure element arranged at least partially in the accommodation space, the pressure element having a flexible portion to clamp an inserted head, and a clamping element extending at least partially around the flexible portion of the pressure element. The clamping element is configured to move from a first position to a second position in which the clamping element exerts a clamping force onto the pressure element, where the movement includes rotating the clamping element around the central axis.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/818,278, filed Nov. 20, 2017, which is a continuation of U.S. patentapplication Ser. No. 15/152,044, filed May 11, 2016, now U.S. Pat. No.9,839,446, which claims the benefit of U.S. Provisional Application Ser.No. 62/160,479, filed May 12, 2015, the contents of which are herebyincorporated by reference in their entirety, and claims priority fromEuropean Patent Application EP 15 167 435.5, filed May 12, 2015, thecontents of which are hereby incorporated by reference in theirentirety.

BACKGROUND Field

The present disclosure relates to a coupling device for coupling a rodto a bone anchoring element. The coupling device includes a receivingpart for receiving a rod and for coupling the rod to a bone anchoringelement. The receiving part is configured to accommodate a head of abone anchoring element such that the head can pivot with respect to thereceiving part. The coupling device further includes a pressure elementwith a flexible portion to clamp a head inserted therein and a clampingelement configured to exert a compression force onto the pressureelement to increase a friction force between the pressure element andthe head.

Description of the Related Art

U.S. Pat. No. 8,926,671 describes a receiving part for receiving a rodand for coupling the rod to a bone anchoring element. The receiving partincludes a receiving part body for accommodating a head of the boneanchoring element and a pressure element with a flexible portion toclamp an inserted head. The pressure element is movable along alongitudinal axis of the receiving part body from an insertion positionwhere the head is insertable into the receiving part body to apre-locking position where the head is clamped in the receiving partbody by a pre-stress exerted by the pressure element. The pressureelement is further movable to a locking position where the head islocked in the receiving part body. The pre-stress exerted by thepressure element allows a desired angular position of the bone anchoringelement to be maintained relative to the receiving part by frictionbefore the head of the bone anchoring element is finally locked.

U.S. Pat. No. 6,248,105 B1 describes a device for connecting alongitudinal rod with a bone anchoring element, such as a pedicle screw,thereby forming a fixation system for the spine. The device includes aconnecting member accepting a longitudinal rod. A radially compressiblespring chuck is arranged within the connecting member that has a cavityfor receiving a head of the bone anchoring element. An insert slidesinto a bore hole of the connecting member and has a recess with acomplementarily conical shape to a conical shape of the spring chuck.The insert radially compresses the spring chuck at an interface betweenthe conical shapes and therewith fastens the head of the pedicle screw.

U.S. Pat. No. 8,951,294 B2 describes a spinal implant with an anchoringpart and a mounting part with an internal axial housing to transverselyreceive a connecting rod. The spinal implant includes retaining elementsthat are situated near the bottom of the axial housing of the mountingpart. The retaining elements are adapted to fasten a locking member in astationary locking position in which a ball joint connection, formed byfirst and second connecting elements, is locked to fasten the anchoringpart and the mounting part in rotation relative to each other about atleast two orthogonal axes.

US 2013/0096622 A1 describes a polyaxial bone anchoring device having apressure element that exerts pressure onto a head of an anchoringelement. The pressure element maintains the head in an adjustableangular position relative to a receiving part by friction using threadedset screws. A desired friction force can be achieved by controlling thethread turning and advancement of the set screws.

SUMMARY

Embodiments of the invention provide an improved coupling device and animproved bone anchoring device that facilitates handling during surgery.

The coupling device allows adjusting a friction force exerted on a headof a bone anchoring element in an easy manner during surgery. Thecoupling device may be particularly useful for a polyaxial boneanchoring element of the bottom loading type, where the head of the boneanchoring element is inserted into a receiving part from a bottom endthereof. More particularly, the coupling device allows the receivingpart to be placed onto a head of a bone anchoring element in-situ, aftera shaft of the bone anchoring element has already been inserted into abone. Hence, in one or more embodiments, an in-situ type bottom loadingbone anchoring element is provided, where a friction force acting ontothe head can be increased by actuating a clamping element of thecoupling device. By frictional clamping of the head before final lockingof the bone anchoring device, the procedure of aligning a plurality ofreceiving parts for inserting a rod is considerably simplified.

In one embodiment, the clamping element cooperates with a portion of thereceiving part according to a bayonet-like locking advancementstructure, where an engagement member, such as a pin, engages a helicalgroove that allows the clamping element to advance in an axial directionwhile rotating. The advancement is stepless, thereby providing astepless adjustment of the clamping force onto the head. The interactionbetween the engagement member and the helical groove may be self-lockingsuch that a desired position of the clamping element relative to thereceiving part can be selected and secured against inadvertent movement.

In another embodiment, an advancement structure that permits an axialadvancement of the clamping element is formed by a threaded connectionbetween the clamping element and the receiving part. The advancementstructure also allows the clamping element to advance relative to thereceiving part in a stepless manner and to adjust the friction forceacting on the pressure element in a stepless manner. A pitch of thethreaded connection may be the same as a pitch of a threaded connectionbetween the receiving part and a locking element such that the clampingelement can be screwed into the receiving part in the same manner as thelocking element.

In a further embodiment, the clamping element is an open ring similar toa snap ring that can exert a compression force onto the pressure elementwhen the clamping element is placed around the pressure element. Theclamping element has protrusions at a side of the clamping elementfacing the pressure element. In a first condition, the protrusions restin recesses of the pressure element. In a second condition, theprotrusions are moved out of the recesses thereby enhancing the clampingforce on the pressure element. Hence, the clamping force can beincreased with only a minimal movement of the clamping element.

The pressure element may have at least one longitudinal slot providing aflexible portion for clamping the head. In one embodiment, the pressureelement may have an additional horizontal slot to reduce an insertionforce of the head into the pressure element.

In a still further embodiment, the pressure element, the clampingelement, and preferably also the receiving part are manufactured as amonolithic piece. In this embodiment, the connection between thepressure element and the clamping element and preferably also theconnection between the clamping element and the receiving part each haveat least one predetermined breaking point. By exerting a force, forexample by rotating the clamping element, the connection breaks at thepredetermined breaking point. Thereafter, the pieces are separate parts.An additive manufacturing method can be used to manufacture themonolithic pieces, such as laser sintering or electron beam melting.Thereby, sophisticated structures may be produced.

BRIEF DESCRIPTION OF THE DRAWINGS

Further features and advantages will become apparent from thedescription of embodiments by means of the accompanying drawings. In thedrawings:

FIG. 1 shows an exploded perspective view of a first embodiment of abone anchoring device with a first embodiment of a coupling device;

FIG. 2 shows a cross-sectional view of the bone anchoring device of FIG.1 in an assembled state, the cross-section taken in a planeperpendicular to a rod axis;

FIG. 3 shows a perspective view from above a receiving part of thecoupling device according to the first embodiment of FIGS. 1 and 2;

FIG. 4 shows a perspective view from below the receiving part of FIGS. 1to 3;

FIG. 5 shows a top view of the receiving part of FIGS. 3 and 4;

FIG. 6 shows a cross-sectional view of the receiving part of FIGS. 3 to5, the cross-section taken along line A-A in FIG. 5;

FIG. 7 shows a perspective view from above a pressure element of thecoupling device according to the first embodiment of FIGS. 1 and 2;

FIG. 8 shows a perspective view from below the pressure element of FIG.7;

FIG. 9 shows a top view of the pressure element of FIGS. 7 and 8;

FIG. 10 shows a cross-sectional view of the pressure element of FIGS. 7to 9, the cross-section taken along line B-B in FIG. 9;

FIG. 11 shows a perspective view from above a clamping element of thecoupling device according to the first embodiment of FIGS. 1 and 2;

FIG. 12 shows another perspective view of the clamping element of FIG.11;

FIG. 13 shows a top view of the clamping element of FIGS. 11 and 12;

FIG. 14 shows a cross-sectional view of the clamping element of FIGS. 11to 13, the cross-section taken along line CC-CC in FIG. 13;

FIGS. 15a to 15c show cross sectional views of steps of placing thecoupling device according to the first embodiment of FIGS. 1 to 14 ontoa bone anchoring element;

FIGS. 15d to 15f show cross-sectional views of steps of adjusting aclamping force onto an inserted head via the clamping element accordingto the first embodiment of FIGS. 1 to 14;

FIG. 16 shows an exploded perspective view of a second embodiment of abone anchoring device with a second embodiment of a coupling device;

FIG. 17 shows a cross-sectional view of the bone anchoring device ofFIG. 16, the cross-section taken in a plane perpendicular to a rod axis;

FIG. 18 shows a partial cross-sectional view of the bone anchoringdevice of FIGS. 16 and 17 without an inserted rod;

FIG. 19 shows a perspective view from above a receiving part of thecoupling device according to the second embodiment of FIGS. 16 to 18;

FIG. 20 shows a cross-sectional view of the receiving part of FIG. 19,the cross-section taken in a plane perpendicular to the rod axis;

FIG. 21 shows a perspective view from above a clamping element of thecoupling device according to the second embodiment of FIGS. 16 to 18;

FIG. 22 shows a perspective view from below the clamping element of FIG.21;

FIG. 23 shows a side view of the clamping element of FIGS. 21 and 22;

FIG. 24 shows an exploded perspective view of a third embodiment of abone anchoring device with a third embodiment of a coupling device;

FIG. 25 shows a cross-sectional view of the bone anchoring device ofFIG. 24, the cross-section taken in a plane perpendicular to the rodaxis;

FIG. 26 shows a partial cross-sectional view of the bone anchoringdevice of FIGS. 24 and 25;

FIG. 27 shows a perspective view from above a pressure element of thecoupling device according to the third embodiment of FIGS. 24 to 26;

FIG. 28 shows a perspective view from below the pressure element of FIG.27;

FIG. 29 shows a top view of the pressure element of FIGS. 27 and 28;

FIG. 30 shows a cross-sectional view of the pressure element of FIGS. 27to 29, the cross-section taken along line D-D in FIG. 29;

FIG. 31 shows an exploded perspective view of a fourth embodiment of abone anchoring device with a fourth embodiment of a coupling device;

FIG. 32 shows a cross-sectional view of the bone anchoring device ofFIG. 31, the cross-section taken in a plane perpendicular to a rod axis;

FIG. 33 shows a partial cross-sectional view of the bone anchoringdevice of FIGS. 31 and 32 without an inserted rod;

FIG. 34 shows a perspective view from above a receiving part of thecoupling device of FIGS. 31 to 33;

FIG. 35 shows a perspective view from below the receiving part of FIG.34;

FIG. 36 shows a top view of the receiving part of FIGS. 34 and 35;

FIG. 37 shows a cross-sectional view of the receiving part of FIGS. 34to 36, the cross-section taken along line E-E in FIG. 36;

FIG. 38 shows a perspective view from above a pressure element of thefourth embodiment of FIGS. 31 to 33;

FIG. 39 shows a perspective view from below the pressure element of FIG.38;

FIG. 40 shows a top view of the pressure element of FIGS. 38 and 39;

FIG. 41 shows a cross-sectional view of the pressure element of FIGS. 38to 40, the cross-section taken along line F-F in FIG. 40;

FIG. 42 shows a perspective view from above a clamping element of thefourth embodiment of FIGS. 31 to 33;

FIG. 43 shows a perspective view from below the clamping element of FIG.42;

FIG. 44 shows a top view of the clamping element of FIGS. 42 and 43;

FIG. 45 shows a side view of the clamping element of FIGS. 42 to 44;

FIGS. 46a to 46d show steps of mounting the pressure element and theclamping element to the receiving part according to the fourthembodiment of FIGS. 31 to 45;

FIGS. 46e to 46h show steps of mounting the coupling device according tothe fourth embodiment of FIGS. 31 to 45 onto a bone anchoring elementand adjusting a friction force onto an inserted head with the clampingelement;

FIG. 47a shows a perspective view from above a fifth embodiment of acoupling device;

FIG. 47b shows an enlarged view of a detail of FIG. 47 a;

FIG. 48 shows a cross-sectional view of the coupling device of the fifthembodiment of FIGS. 47a and 47 b;

FIG. 49 shows a top view of the coupling device of FIGS. 47a to 48; and

FIG. 50 shows a cross-sectional view of the coupling device of FIGS. 47to 49, the cross-section taken along line G-G in FIG. 49.

DETAILED DESCRIPTION

As shown in FIGS. 1 and 2, a bone anchoring device according to a firstembodiment includes a bone anchoring element 1. The bone anchoringelement 1 may be a bone screw having a threaded shaft 2 and a head 3that may be spherically segment-shaped. The head 3 has a recess 3 a forengagement with a screwing-in tool. The bone anchoring device furtherincludes a coupling device for receiving a rod 100 to connect the rod100 to the bone anchoring element 1. The coupling device includes areceiving part 5 for receiving the rod 100 and the head 3 of the boneanchoring element 1. The coupling device also has a pressure element 6for exerting a pressure on the head 3 of the bone anchoring element 1that has been inserted therein to clamp and finally lock the head 3 inthe receiving part 5. Additionally, a clamping element 7 is provided forexerting a compression force onto the pressure element 6 to increase thepressure force on the inserted head 3. The bone anchoring device furtherincludes a locking element 8 for securing the rod 100 in the receivingpart 5 and for exerting a force to lock the head 3 in the receiving part5. The locking element 8 may be, for example, a set screw.

The receiving part 5 is now explained with reference to FIGS. 1 to 6.The receiving part 5 includes a first end or proximal end 5 a, a secondend or distal end 5 b opposite the first end 5 a, and an axis ofsymmetry C passing through the first end 5 a and the second end 5 b. Apassage 51 is provided that extends from the first end 5 a to the secondend 5 b and is substantially rotationally symmetric about the axis ofsymmetry C. In a first region adjacent to the first end 5 a, thereceiving part 5 has a substantially U-shaped recess 52 that issymmetric with respect to the axis C, the recess 52 having a bottomdirected towards the second end 5 b. The recess 52 forms two freelateral legs 53 a, 53 b that extend towards the first end 5 a. Aninternal thread 54 is provided in each of the legs 53 a, 53 b thatcooperates with the locking element 8. The internal thread 54 may be aflat thread (as shown in FIG. 2) to eliminate spreading of the legs 53a, 53 b when tightening the locking element 8. The internal thread 54may, however, have any other suitable thread form. An undercut 54 a maybe provided at a bottom end of the internal thread 54 (i.e., at an endof the internal thread 54 closest to the second end 5 b of the receivingpart 5). The undercut 54 a may have a depth in a radial direction of thereceiving part 5 that is substantially the same as the depth of thethread 54 in the radial direction.

A channel formed by the substantially U-shaped recess 52 is sized toreceive the rod 100 therein, where the rod 100 is configured to connecta plurality of anchoring devices.

As can be seen in particular in FIGS. 2 and 6, a portion of the passage51 in an upper section of the receiving part 5 between the first end 5 aand approximately the bottom of the U-shaped recess 52 is substantiallycylindrical. At approximately the bottom of the U-shaped recess 52, thepassage 51 widens, for example conically, to form an accommodation space55 that has an inner diameter greater than an inner diameter of thepassage 51 located in the upper section of the receiving part 5. Theaccommodation space 55 narrows towards the second end 5 b with anarrowing portion 55 a extending from a projecting edge 55 b to thesecond end 5 b. A size of the accommodation space 55 is such that thehead 3 of the bone anchoring element 1 and a lower portion of thepressure element 6 can be accommodated therein. The passage 51 forms anopening 56 at the second end 5 b that opens into the accommodation space55. A diameter of the opening 56 is greater than a greatest diameter ofthe head 3 such that the head 3 is insertable into the receiving part 5through the opening 56 at the second end 5 b. It should be noted thatthe narrowing portion 55 a can narrow in several shapes, such as atapered shape as shown in FIGS. 2 and 6, a spherical shape, or cannarrow otherwise.

At a distance from the first end 5 a, circumferentially extendingnotches 58 a, 58 b with downwardly inclined upper and lower surfaces maybe provided for engagement with a tool.

On each of the legs 53 a, 53 b, bores 59 a, 59 b, extending through thelegs 53 a, 53 b, respectively, are provided for receiving pins 9 a, 9 b.The bores 59 a, 59 b are located approximately at a center of each leg53 a, 53 b in a circumferential direction of the receiving part 5 andare offset from each other by approximately 180°.

Referring to FIGS. 7 to 10, the pressure element 6 has a first end 6 aand an opposite second end 6 b. The pressure element 6 is configured tobe mounted to the receiving part 5 such that the second end 6 b of thepressure element 6 is directed towards the second end 5 b of thereceiving part 5. The pressure element has a first portion 61 adjacentto the first end 6 a that is substantially cylindrical and that has anouter diameter that is smaller than an inner diameter of the passage 51of the receiving part 5. In the cylindrical first portion 61, a recesswith a substantially V-shaped cross-section is formed that provides arod support surface 62 for supporting an inserted rod 100. The V-shapepermits the pressure element 6 to support rods of different diameters.Inserted rods to be supported contact the rod support surface 62 with atleast two contact lines extending perpendicular to the cylinder axis ofthe first portion 61. When the pressure element 6 is in a mounted statein the receiving part 5, the cylinder axis of the first portion 61coincides with the central axis of symmetry C of the receiving part 5.

A second portion 63 of the pressure element 6 is between the cylindricalfirst portion 61 and the second end 6 b with a hollow interior 64 havinga shape adapted to clamp the head 3 therein. In particular, the hollowinterior 64 of the second portion 63 has a spherical shape with a lengthin an axial direction of the pressure element 6 sufficient toaccommodate a greatest diameter e of the head 3 therein (see FIG. 2). Asdescribed in more detail below, the second portion 63 is open at thesecond end 6 b to allow insertion of the head 3 of the bone anchoringelement 1 into the hollow interior 64 from the second end 6 b. An outerwall of the second portion 63 includes a first outer surface portion 65that is substantially spherical and a second outer surface portion 66adjacent to the second end 6 b that narrows towards the second end 6 b.In particular, in the embodiment shown, the second outer surface portion66 is tapered. As can be seen in FIG. 2, a largest outer diameter of thefirst outer surface portion 65 of the pressure element 6 is smaller thana greatest inner diameter of the accommodation space 55 and greater thanan inner diameter of the opening 56 of the receiving part 5. The secondportion 63 of the pressure element 6 further has at least one verticalslit 67, preferably a plurality of slits 67, that are open to the secondend 6 b and extend from a bottom of the second portion 63 almost up tothe first portion 61. The at least one vertical slit 67 may widen into asubstantially circular enlarged end portion 68 forming a closed end ofthe slit 67. The enlarged end portion 68 of the slits 67 can haveanother shape, for example, an oval shape, or any other shape that isdifferent from the slits 67. In some embodiments, the enlarged endportion 68 can be omitted such that each slit 67 has the same width atits closed end as at its respective open end. The number and dimensionsof the slits 67 are such that the wall of the second portion 63 isflexible enough to snap onto the head 3 when the head 3 is inserted intothe hollow interior 64.

The second portion 63 of the pressure element 6 is a flexible portionthat is adapted to exert a pressure onto an inserted head 3 and to holdthe head 3 by a frictional force between an inner surface of the hollowinterior 64 of the second portion 63 and an outer surface of the head 3.The flexible portion 63 is a cap-like portion that fits tightly onto thehead 3. In addition, it shall be noted that the second outer surfaceportion 66 of the pressure element 6 may have another shape, forexample, a rounded shape or any other shape suitable to cooperate withthe narrowing portion 55 a of the receiving part 5 such that the outersurface portion 66 can be compressed when it enters into the narrowingportion 55 a of the receiving part 5.

The pressure element 6 is configured to be inserted into the receivingpart 5 through the lower opening 56, whereby the second portion 63 iscompressed during insertion. Alternatively, the pressure element 6 maybe inserted into the first end 5 a of the receiving part 5 and moveddownwardly or distally through the passage 51. The outer diameter of thecylindrical first portion 61 of the pressure element 6 is smaller thanthe inner diameter of the passage 51 such that the clamping element 7fits there-between. Because the second portion 63 of the pressureelement 6 has an outer diameter that is smaller than an inner diameterof the accommodation space 55 and has a flexible wall, the secondportion 63 can expand within the accommodation space 55 when the head 3is inserted into the hollow interior 64 of the pressure element 6.

Further, the pressure element 6 includes a coaxial bore 69 providingaccess to the head 3 by a tool configured to engage the engagementrecess 3 a of the head 3.

Referring to FIGS. 11 to 14, the clamping element 7 is a ring-shapedpart. The ring is closed and is not flexible. The clamping element 7 hasa first end 7 a, an opposite second end 7 b, and a substantiallycylindrical outer shape. As depicted in FIG. 2, the clamping element 7is configured to be mounted to the receiving part 5 such that the secondend 7 b of the clamping element 7 is directed towards the second end 5 bof the receiving part 5. When the clamping element 7 is in a mountedstate in the receiving part 5, the cylinder axis of the clamping element7 coincides with the central axis of symmetry C of the receiving part 5.As depicted in FIG. 2, an outer diameter of the clamping element 7 isslightly smaller than an inner diameter of the passage 51 in the uppersection of the receiving part 5. As such, the clamping element 7 can beinserted into the first end 5 a of the receiving part 5 and moveddownwardly or distally through the passage 51.

As can be seen, for example, in FIGS. 2 and 14, an inner surface 71 ofthe clamping element adjacent to the first end 7 a is cylindrical withan inner diameter slightly larger than an outer diameter of the firstportion 61 of the pressure element 6. The cylindrical surface 71 of thering-shaped clamping element 7 encompasses the outer cylindrical surfaceof the first portion 61 of the pressure element 6 in the mounted state.In addition, the clamping element 7 has a conically widening innersurface portion 72 between the cylindrical inner surface 71 and thesecond end 7 b. The size of the conically widening inner surface portion72 is such that the clamping element 7 can be mounted around thepressure element 6 with the inner surface portion 72 encompassing anupper region of the flexible second portion 63 of the pressure element6. Thereby, the inner surface portion 72 contacts the first outersurface portion 65 of the flexible second portion 63 of the pressureelement 6. By a downward movement of the clamping element 7 relative tothe receiving part 5, the flexible second portion 63 of the pressureelement 6 is compressed. Further, the inner surface portion 72 may haveanother shape that includes an increase in inner diameter towards thesecond end 7 b.

Referring in particular to FIGS. 11 and 12, two helical grooves 73 a, 73b having the same pitch are provided on the outer surface of theclamping element 7. The helical grooves 73 a, 73 b are open towards thefirst end 7 a and have closed ends 74 a, 74 b towards the second end 7b. The closed ends 74 a, 74 b may have rounded contours. A width of thegrooves 73 a, 73 b is only slightly larger than the diameter of the pins9 a, 9 b. In particular, the width of the grooves 73 a, 73 b in relationto the diameter of the pins 9 a, 9 b and the pitch may be such that africtional force between the pins 9 a, 9 b and the grooves 73 a, 73 bresults in a self-locking connection whereby the clamping element 7 canadvance relative to the pins 9 a, 9 b only if a force is applied thatexceeds the self-locking force. An inclination of the grooves 73 a, 73 band a length of the grooves 73 a, 73 b between the open ends and theclosed ends 74 a, 74 b is such that a desired advancement of theclamping element 7 in relation to an inserted pin 9 a, 9 b is possible.In the embodiment depicted in FIGS. 11 and 12, the grooves 73 a, 73 beach extend around the central axis C by more than around 90° and lessthan around 180°. However, any other inclination and length of thegrooves 73 a, 73 b may be selected such that the clamping element 7 canbe moved relative to the inserted pins 9 a, 9 b with a predeterminedincrement. The grooves 73 a, 73 b and the pins 9 a, 9 b form anadvancement structure that permits the clamping element 7 to advance inthe receiving part 5 by rotating the clamping element 7 around the axisof symmetry C. When the pressure element 6 and the clamping element 7are inserted into the receiving part 5, the closed ends 74 a, 74 b ofthe helical grooves 73 a, 73 b prevent the clamping element 7 fromescaping through the first end 5 a. As such, the closed ends 74 a, 74 bform a securing structure.

As further depicted in FIGS. 11 to 14, the clamping element 7 includes aplurality of engagement portions or recesses 75 in the surface of thefirst end 7 a that are configured to be engaged with a tool used forrotating the clamping element 7.

The parts of the bone anchoring device can be made of a bio-compatiblematerial, such as a bio-compatible metal or a bio-compatible metalalloy, for example stainless steel, titanium, NiTi-alloys, such asNitinol, magnesium or magnesium alloys or from a bio-compatible plasticmaterial, such as, for example, polyether ether ketone (PEEK) orpoly-l-lactide acid (PLLA). The parts of the bone anchoring device canbe made of the same or of different materials.

Referring to FIGS. 15a to 15c , steps of assembling the bone anchoringdevice of FIGS. 1 to 14 are explained. In FIG. 15a the pressure element6 and the clamping element 7 are inserted into the receiving part 5. Thepressure element 6 is in a position in which the second outer surfaceportion 66 of the pressure element abuts against the narrowing portion55 a of the receiving part 5. The pressure element 6 may be insertedfrom the lower opening 56 at the second end 5 b or may be insertedthrough the first end 5 a and moved downwardly or distally through thepassage 51. The clamping element 7 is mounted such that the pins 9 a, 9b rest in the closed end portion 74 a, 74 b of the helical grooves 73 a,73 b, respectively, in an uppermost or first position of the clampingelement 7. In this position, the clamping element 7 is arranged aroundthe cylindrical first portion 61 of the pressure element 6 and does notcontact the flexible second portion 63. Next, as depicted in FIG. 15b ,the head 3 of the bone anchoring element is inserted into the pressureelement 6 and the receiving part 5 through the lower opening 56 of thereceiving part 5. In a first alternative, the bone anchoring device isassembled in-situ such that the bone anchoring element 1 has beenalready inserted into the bone and the coupling device, including thereceiving part 5 with the pressure element 6 and the clamping element 7,is thereafter mounted onto the head 3 (arrow a1). In a secondalternative, the bone anchoring device is assembled outside the humanbody and the head 3 is inserted manually into the receiving part 5through the lower opening 56 before the bone anchoring element 1 isanchored to the bone.

Next, as depicted in FIG. 15c , the head 3 moves the pressure element 6upward and the head 3 snaps into the hollow interior 64 of the flexibleportion 63 of the pressure element 6. When the greatest diameter e ofthe head 3 passes the second end 6 b of the pressure element and movesinto the hollow interior 64, the flexible portion 63 can expand in theaccommodation space 55 of the receiving part 5. During this step, theclamping element 7 stays in a fixed axial position and cannot be pushedupward or proximally as the clamping element 7 is held by the pins 9 a,9 b.

FIGS. 15d to 15f illustrate steps of achieving and adjusting africtional clamping of the head 3. As depicted in FIG. 15d , when thehead 3 has been fully inserted into the pressure element 6, thereceiving part 5 may be pulled upwards (arrow b1), whereby the pressureelement 6 together with the inserted head 3 is moved downward relativeto the receiving part 5. The second outer surface portion 66 of thepressure element 6 passes the edge 55 b protruding into theaccommodation space 55 and enters the narrowing portion 55 a whereby thesecond outer surface portion 66 is compressed and the head 3 is clampedby friction. In addition, the head 3 can no longer be removed throughthe lower opening 56 due to the force of the pressure element 6. Thisposition is a pre-locking position of the pressure element 6.

In order to allow in-situ mounting of the receiving part 5 onto the head3, a required insertion force for inserting the head 3 into the pressureelement 6 should not be too high. However, if the insertion force is toolow, resultant frictional clamping of the pressure element 6 onto thehead 3 after insertion of the head 3 might not be strong enough forconvenient handling.

To enhance frictional clamping of the head 3, the clamping element 7 isactuated in a next step using a tool 150 as shown in FIGS. 15e and 15f .The tool 150 may be formed as a tubular rod with engagement portions ata front or distal end that are arranged and sized to engage (e.g., fitin) the engagement portions 75 of the clamping element 7. The clampingelement 7 is rotated by rotation of the tool 150 such that the pins 9 a,9 b are guided in the helical grooves 73 a, 73 b. Thereby, the clampingelement 7 advances downward until the inner surface portion 72 of theclamping element 7 contacts the first outer surface portion 65 of thepressure element 6. Further rotation of the tool 150 advances theclamping element 7 such that the clamping element 7 exerts a compressionforce onto the flexible second portion 63 of the pressure element 6which increases the pressure of the pressure element 6 onto the insertedhead 3. As a result thereof, the frictional force that holds the head 3in a desired angular position relative to the receiving part 5 beforefinal locking is increased. Due to the bayonet-like advancementstructure of the clamping element 7, a stepless advancement of theclamping element 7 relative to the receiving part 5 is possible, whichin turn provides a stepless adjustment of the compression force onto thehead 3. FIG. 15f depicts a partial cross-sectional view whichillustrates how the groove 73 b has moved relative to the mounted pin 9b. With a self-locking connection between the groove 73 b and the pin 9b, a desired position of the clamping element 7 in the receiving part 5can be selected and maintained.

Finally, after alignment of the receiving part 5 of several boneanchoring devices, the rod 100 is inserted and the locking element 8 istightened. Thereby, the pressure element 6 is further pressed againstthe narrowing portion 55 a to lock the bone anchoring devices.

A second embodiment of the bone anchoring device and of the couplingdevice will be described with reference to FIGS. 16 to 23. Parts,portions, and elements that are identical or similar to those of thefirst embodiment are marked with the same reference numerals, and thedescriptions therefore will not be repeated. The second embodimentdiffers from the first embodiment in the design of the clamping elementand the advancement structure. All other parts are the same as in thefirst embodiment.

As depicted in FIGS. 16 to 20, the receiving part 5′ includes aninternal thread 90 that extends from the lower end of the internalthread 54 to an axial height of approximately slightly below the bottomof the U-shaped recess 52. The internal thread 90 may be separated fromthe internal thread 54 by the undercut 54 a. A thread pitch of theinternal thread 90 is substantially the same as a thread pitch of theinternal thread 54 and a major diameter of the internal thread 90 islarger than a minor diameter of the internal thread 54. The shape of theinternal thread 90 may be different from the shape of the internalthread 54. For example, the thread flanks of the internal thread 90 mayhave a triangular cross-section or any other cross-section. However, thedimensions of the threads of the internal thread 90 should be such thatthe clamping element 7 can be screwed through the upper portion of thepassage 51 having the internal thread 54 and into the portion of thepassage 51 having the internal thread 90. It should be noted, that thereceiving part 5′ does not need to have the pins 9 a, 9 b in thisembodiment.

As shown in FIGS. 21 to 23, the clamping element 7′ includes an externalthread 73′ provided on its outer cylindrical surface that is configuredto cooperate with the internal thread 90 of the receiving part 5′. Atthe first end 7 a, the clamping element 7′ may have a plurality ofengagement recesses 75′. In particular, the number of engagementrecesses 75′ may be greater than in the first embodiment. Theadvancement structure in the form of the cooperating threads 73′, 90provides a stepless advancement of the clamping element 7′ relative tothe receiving part 5′. The threaded connection between the clampingelement 7′ and the receiving part 5′ acts as a securing structure thatinhibits inadvertent movement of the clamping element 7′ relative to thereceiving part 5′.

In use, after the pressure element 6 has been inserted into thereceiving part 5′, the clamping element 7′ is mounted to the receivingpart 5′ by screwing the clamping element 7′ downward from the first end5 a. The clamping element 7′ is moved downward to an axial position thatstill allows the pressure element 6 to move upward or proximally toinsert the head 3. Screwing-in the clamping element 7′ renders theassembly simple and safe, as jamming of the clamping element 7′ in thepassage 51 is prevented.

When the head 3 has been inserted into the pressure element 6 and thepressure element 6 has reached the pre-locking position shown in FIG.17, the clamping element 7′ can be further screwed downward with a toolto exert a compression force onto the pressure element 6 to enhance theclamping force acting onto the head 3 by friction. After the rod 100 hasbeen inserted and the locking element 8 has been tightened, the pressureelement 6 is further pressed against the narrowing portion 55 a to lockthe bone anchoring device.

A third embodiment of the bone anchoring device will be described withreference to FIGS. 24 to 30. Parts, portions and elements of the thirdembodiment that are identical or similar to those of the firstembodiment are marked with the same reference numerals and thedescriptions thereof will not be repeated. The bone anchoring devicediffers from the first embodiment in the design of the coupling deviceand in particular in the design of the pressure element. The couplingdevice of the third embodiment includes the receiving part 5 and theclamping element 7 of the first embodiment and a modified pressureelement 6′.

As shown, for example, in FIGS. 27-30, the flexible second portion 63′of the pressure element 6′ includes one single vertical slit or recess67′ that is provided at an angle of substantially 90° in acircumferential direction relative to a longitudinal axis of theV-shaped rod support surface 62. The vertical recess 67′ is open towardsthe second end 6 b of the pressure element 6′. At a distance from thesecond end 6 b, the vertical recess 67′ opens into a horizontal recess68′ that extends in a circumferential direction from both sides from thevertical recess 67′. The horizontal recess 68′ extends to ends that arespaced apart from each other. By means of the vertical recess 67′ andthe horizontal recess 68′, a ring 65 a is formed that is connected tothe other portions of the pressure element 6′. The ring 65 a is flexibleand can be expanded and/or compressed. An upper portion of the pressureelement 6′ between the horizontal recess 68′ and the cylindrical portion61 has a substantially spherical outer surface that is slightly recessedwith respect to the ring 65 a. In other words, the ring 65 a has aslightly greater outer diameter forming a circumferential edge 65 b.

As depicted in FIGS. 25 and 26, in the assembled state when the clampingelement 7 has been moved downward to contact the pressure element 6′,the clamping element 7 presses the pressure element 6′ with the innersurface portion 72 onto the edge of the ring 65 a that has the slightlygreater diameter.

The use of the bone anchoring device according to the third embodimentis analogous to the use of the bone anchoring devices according to theprevious embodiments. However, the horizontal slit 68′ in connectionwith the vertical slit 67′ renders the second portion 63′ of thepressure element 6′ more flexible than the previous embodiments.Therefore, the amount of insertion force required to insert the head 3into the pressure element 6′ may be decreased relative to previousembodiments. In turn, the amount of frictional force needed to hold theinserted head 3 in the pressure element 6′ and the receiving part 5 maybe smaller. By means of the clamping element 7, the frictional force canbe increased relative to previous embodiments.

A fourth embodiment of the bone anchoring device will be explained withreference to FIGS. 31 to 45. Parts, portions and elements that areidentical or similar to the parts, portions and elements of the previousembodiments are indicated with the same reference numerals and thedescriptions thereof will not be repeated. The bone anchoring device ofthe fourth embodiment differs from the previous embodiments in thestructure of the receiving part, the pressure element and the clampingelement.

Referring to FIGS. 31 to 37, the receiving part 5″ is adapted toaccommodate the clamping element 7″. The receiving part 5″ includesopposite horizontal slits 501 a, 501 b on each leg 53 a, 53 b. Theopposite horizontal slits 501 a, 501 b are located at one side of theU-shaped recess 52. The slits 501 a, 501 b extend substantiallyperpendicular to the central axis C and are open towards the outersurface of the legs 53 a, 53 b. At their outer region, the slits 501 a,501 b may have a substantially square or rectangular cross-section witha size adapted to accommodate at least a portion of the clamping element7″ therein. The slits 501 a, 501 b are located at an axial position thatis approximately at the lower end of the internal thread 54, whichallows mounting the clamping element 7″ to the receiving part 5″ fromthe side through the U-shaped recess 52.

At the side of the slits 501 a, 501 b, a substantially verticallyextending shallow recess 502 is provided that extends from the bottom ofthe substantially U-shaped recess 52 towards the second end 5 b. A widthof the shallow vertical recess 502 in a circumferential direction isslightly larger than half of the distance between the legs 53 a, 53 b,as can be seen in particular in FIG. 36. The shallow recess 502 servesas a space for a portion of the clamping element 7″ to permit theclamping element 7″ to rotate between a first position and a secondposition and to limit the movement of the clamping element 7″ betweenthese positions. Moreover, two opposite bores 59 a′, 59 b′ are providedat approximately the center of the legs 53 a, 53 b and at an axialposition slightly below the axial position of the horizontal slits 501a, 501 b. The bores 59 a′, 59 b′ are configured to accommodate pins 9a′, 9 b′, respectively therein. The pins 9 a′, 9 b′ are configured toengage the pressure element 6″ as explained below.

Turning now to FIGS. 38 to 41, the pressure element 6″ differs from thepressure element of the first and second embodiments by the shape of theupper portion adjacent to the flexible second portion 63. The flexiblesecond portion 63 is identical to the flexible second portion 63 of thefirst embodiment. The cylindrical first portion 61′ has an outerdiameter that is greater than an outer diameter of the flexible secondportion 63 in the upper region, hence, the flexible second portion 63 isrecessed with respect to the first portion 61′. The first portion 61′includes two opposite upstanding legs 61 a, 61 b. Grooves 62 a, 62 brespectively separate the upstanding legs 61 a, 61 b from an innerportion having the rod supporting surface 62. The grooves 62 a, 62 b mayhave a widened bottom to render the legs 61 a, 61 b slightly flexible toaid with insertion. The grooves 62 a, 62 b extend substantially parallelto the longitudinal axis of the rod support surface 62. An inner surfaceof the legs 61 a, 61 b is substantially flat. At an upper end of thelegs 61 a, 61 b, the legs 61 a, 61 b each include collar portions 600 a,600 b. The collar portions 600 a, 600 b are shaped to fit in acorresponding cutout in the receiving part 5″ in the region of thehorizontal slits 501 a, 501 b, as shown in particular in FIG. 33. Thelegs 61 a, 61 b each include an elongate through-hole 601 a, 601 b, thelongitudinal axes of which are substantially parallel to the centralaxis C. The through-holes 601 a, 601 b are configured to receive thepins 9 a′, 9 b′, respectively. When the pins 9 a′, 9 b′ engage thethrough-holes 601 a, 601 b, the pressure element 6″ is restricted tomove only a predetermined distance in the axial direction and is limitedby the abutment of the pins 9 a′, 9 b′ against the respective ends ofthe through-holes 601 a, 601 b in the axial direction.

The clamping element 7″ of the fourth embodiment will be explained withreference to FIGS. 31 to 33 and 42 to 45. The clamping element 7″ isshaped as an open ring having free ends 70 a, 70 b and a slot 700therebetween such that the clamping element 7″ can act as a snap ring.More in detail, the clamping element 7″ extends slightly more than 180°in a circumferential direction around the central axis C. The slot 700may be smaller or may be larger than as shown. Further, the clampingelement 7″ has a substantially cylindrically shaped outer wall with anaxial length such that the clamping element 7″ fits approximately into arecessed region between the first portion 61′ and the second portion 63of the pressure element 6″, as shown in FIG. 32. As further depicted inFIG. 32, the clamping element 7″ has a substantially conically wideninginner surface portion 720 that is adapted to extend around the uppersection of the flexible second portion 63 of the pressure element 6″.Between the widening inner surface portion 720 and the first end 7 a ofthe clamping element 7″, there may be a portion 710 that can be roundedto avoid jamming of the clamping element 7″ during mounting. A pluralityof rounded protrusions 721 are provided in the widening inner surfaceportion 720 that are configured to engage the widened end portions 68 ofthe slits 67 of the flexible portion 63 of the pressure element 6″. Itshall be noted that a modification of the design of the pressure element6″ and the clamping element 7″ may be conceivable. Instead of thewidened portions 68 of the slit 67 in the pressure element 6″ and therounded protrusions 721 on the inner surface of the clamping element 7″,protrusions could be present at the end of the slits 67 of the pressureelement 6″ and corresponding dimples could be present in the innersurface of the clamping element 7″.

At approximately the center of the clamping element 7″ in acircumferential direction, a protrusion 730, with a substantiallyrectangular cross-section, is provided at the outer surface of theclamping element 7″ opposite to the protrusions 721. In the axialdirection, the protrusion 730 extends above the first end 7 a. Theprotrusion 730 serves for engagement with a tool for moving the clampingelement 7″ relative to the pressure element 6″.

Mounting of the pressure element 6″ and the clamping element 7″ into thereceiving part 5″ according to the fourth embodiment will be explainedwith reference to FIGS. 46a to 46d . In a first step, the pressureelement 6″ is inserted into the receiving part 5″ from the first end 5a. Upon insertion into the receiving part 5″, the legs 61 a, 61 b may beslightly flexed towards each other such that the pressure element 6″ canbe maintained at a desired axial position. When the region of thepressure element 6″ between the cylindrical first portion 61′ and theflexible second portion 63 is located at an axial height ofapproximately the horizontal slits 501 a, 501 b, the clamping element 7″is inserted into the slits 501 a, 501 b of the receiving part 5″ untilthe clamping element 7″ extends around the pressure element 6″ justbeneath the cylindrical first portion 61′. In this configuration, theprotrusion 730 of the clamping element 7″ is aligned with the center ofthe substantially U-shaped recess of the receiving part 5″, and the rodsupport surface 62 of the pressure element 6″ is also aligned with theU-shaped recess 52 of the receiving part 5″. Further, one of the slits67 is located at a circumferential position corresponding to the centerof the rod support surface 62 of the pressure element 6″. Acorresponding protrusion 721 at the widening inner surface portion 720of the clamping element 7″ can engage the widened portion 68 of the slit67 as depicted in FIG. 46c . Thereafter, as shown in FIG. 46d , thepressure element 6″ and the clamping element 7″ are moved downwardtogether as indicated by the arrow a1. Thereby, the elongatethrough-holes 601 a, 601 b overlap with the bores 59 a′, 59 b′ such thatthe pins 9 a′, 9 b′ can be inserted into the bores 59 a′, 59 b′ andextend into the through-holes 601 a, 601 b.

Use of the bone anchoring device of the fourth embodiment will beexplained with reference to FIGS. 46e to 46h . First, as depicted inFIG. 46e , the receiving part 5″ with the mounted pressure element 6″and clamping element 7″ is placed onto the head 3 of the bone anchoringelement 1. This may be performed in-situ after the bone anchoringelement 1 has been already inserted into the bone. As with the previousembodiments, the pressure element 6″ snaps onto the head 3 such that thehead 3 is accommodated in the pressure element 6″ and in theaccommodation space 55 of the receiving part 5″ as shown in FIG. 46f .Thereafter, as illustrated in FIG. 46g , the receiving part 5″ is pulledupward or proximally according to the arrow b1. The pins 9 a′, 9 b′respectively move upward in the elongate through-holes 601 a, 601 b ofthe pressure element 6″. The protrusion 730 of the clamping element 7″moves at least partially into the shallow recess 502 of the receivingpart 5″. In this position, the pressure element 6″ has reached thepre-locking position where it is no longer possible to remove the head 3through the lower opening 56.

Thereafter, as shown in FIG. 46h , the clamping element 7″ is rotated inthe clockwise direction around the central axis C (arrow c1). Theclamping element 7″ may be rotated using a tool that engages theprotrusion 730 of the clamping element 7″. Thereby, the roundedprotrusions 721 of the clamping element 7″ move out of the wideningportions 68 of the pressure element 6″ and press against the flexiblesecond portion 63 of the pressure element 6″. The compression of therounded protrusions 721 against the flexible second portion 63 of thepressure element 6″ increases the clamping force acting on the head 3.The rotational movement of the clamping element 7″ relative to thereceiving part 5″ is limited by the abutment of the protrusion 730against the sidewall of the shallow recess 502. Moreover, the pins 9 a′,9 b′ prevent the pressure element 6″ from escaping out of the receivingpart 5″.

The steps of inserting the rod 100 and the locking element 8, andtightening the locking element 8 to lock the bone anchoring device areidentical to the previous embodiments.

A fifth embodiment of the polyaxial bone anchoring device and thecoupling device will be described with reference to FIGS. 47a to 50. Thebone anchoring element 1 of the fifth embodiment is identical to theprevious embodiments. The receiving part 5′″, the clamping element 7′″,and the pressure element 6′″ are manufactured as a monolithic piece andare separated after manufacturing. The pressure element 6′″ of the fifthembodiment has a shape similar to the pressure element in the firstembodiment. The clamping element 7′″ of the fifth embodiment is similarto the clamping element of the first and second embodiments, however,instead of the two grooves 73 a, 73 b, the clamping element 7′″ has twohelical projections 7000 a, 7000 b on its outer surface. The helicalprojections 7000 a, 7000 b are configured to engage correspondinghelical grooves 9000 a, 9000 b in the receiving part 5′″. As shown inmore detail in FIGS. 47a and 47b , the clamping element 7′″ ismonolithically connected to the pressure element 6′″ at predeterminedbreaking points P. The predetermined breaking points P are configured tobreak such that the clamping element 7′″ and the pressure element 6′″become separated. The predetermined breaking points P have such a sizethat they break when a tool engages the engagement portions 75 of theclamping element 7′″ and rotates the clamping element 7′″. Similarly,the clamping element 7′″ is monolithically connected to the receivingpart 5′″ at predetermined breaking points Q as shown in FIGS. 48 and 50.The size of the breaking points Q is such that the connection betweenthe receiving part 5′″ and the clamping element 7′″ breaks at thepredetermined breaking points Q by rotation of the clamping element 7′″with a tool.

The receiving part 5′″, the pressure element 6′″, and the clampingelement 7″ may be separated before mounting the coupling device to abone anchoring element 1. In particular, the pressure element 6′″ andthe clamping element 7′″ may be manufactured such that the position ofthe pressure element 6′″ is an inserting position for inserting the head3. The separation can take place during mounting of the receiving part5′″ onto the head 3 of the bone anchoring element 1 in-situ.

A method for manufacturing the coupling device according to the fifthembodiment may be performed by an additive manufacturing method, such asselective laser sintering, selective laser melting, electronbeam-sintering, and/or electron beam-melting.

Modifications of the above described embodiments are possible. For thebone anchoring element all kinds of bone anchors can be used, such asscrews, nails with or without barbs, cannulated bone anchors, two-partbone anchors where head and shaft are separate parts that can beassembled, and other bone anchoring elements. The head of the boneanchoring element may have a design that allows the bone anchoringelement with a pressure element adapted thereto to be pivoted only in asingle plane. For example, the head may have at least one flat surfaceportion extending substantially parallel to the shaft axis and thepressure element may have a cooperating portion to limit the pivoting toa single plane. Any design for providing an enlarged pivot angle may beused also.

For the locking element all kinds of locking devices can be used, suchas bayonet-type locking devices, two-part locking devices that allowclamping the rod and the head independently with two locking elements,outer locking nuts, and the like.

While some of the embodiments include two pins, it shall be understoodthat one pin is sufficient.

The features of the above described embodiments can be combined amongeach other to provide a variety of still further embodiments.

While the present invention has been described in connection withcertain exemplary embodiments, it is to be understood that the inventionis not limited to the disclosed embodiments, but is instead intended tocover various modifications and equivalent arrangements included withinthe spirit and scope of the appended claims, and equivalents thereof.

1. A coupling device for coupling a rod to a bone anchoring element, thecoupling device including a receiving part having a first end and asecond end, a central axis extending through the first end and thesecond end, a channel for receiving a rod, wherein the receiving partdefines an accommodation space for accommodating a head of a boneanchoring element, the accommodation space having an opening forinserting the head; a pressure element arranged at least partially inthe accommodation space, the pressure element comprising a flexibleportion to clamp an inserted head, and a clamping element configured tomove from a first position to a second position in which it exerts aclamping force onto the pressure element.
 2. The coupling device ofclaim 1, wherein when the clamping element is in the first position theclamping force exerted onto the pressure element is smaller than theclamping force exerted in the second position or no clamping force isexerted onto the pressure element.
 3. (canceled)
 4. The coupling deviceof claim 2, wherein the pressure element is formed such that it extendsbeyond a largest diameter of an inserted head towards the second end ofthe receiving part and wherein the clamping element is provided at anaxial position above the largest diameter in the direction of the firstend.
 5. (canceled)
 6. The coupling device of claim 1, wherein anadvancement structure is provided that is configured to permit an axialadvancement of the clamping element. 7-11. (canceled)
 12. The couplingdevice of claim 1, wherein the clamping element shaped as a slotted ringthat extends partially around the pressure element.
 13. The couplingdevice of claim 1, wherein the clamping element comprises protrusions orrecesses at its side facing the pressure element that may cooperate withrecesses or protrusions at the pressure element to secure the firstposition of the clamping element.
 14. (canceled)
 15. A bone anchoringdevice comprising the coupling device of claim 1 and a bone anchoringelement with a shank and a head wherein the head preferably has aspherical outer surface portion.